The Fourth Self-Developed Innovative Drug Enters Pivotal Clinical Stage! Jiangsu Vcare’s VC005 Topical Gel Completes First Patient Enrollment in Phase III Clinical Trial

　　Recently, Jiangsu Vcare PharmaTech Co.,Ltd. (Jiangsu Vcare) announced that VC005 Topical Gel, its self-developed second-generation highly selective JAK1 inhibitor, has completed the enrollment of the first patient in the phase III clinical trial for the treatment of mild-to-moderate atopic dermatitis (AD).

　　This trial is designed to further evaluate the efficacy and safety of VC005 Gel in adult and adolescent patients with mild-to-moderate atopic dermatitis. It marks that this innovative topical therapy with differentiated advantages has fully entered the pivotal clinical research stage, bringing it one step closer to product launch and benefiting a large number of AD patients.

　　As a core product in Jiangsu Vcare’s autoimmune disease pipeline, VC005 Topical Gel is a novel locally exposed second-generation highly selective JAK1 inhibitor for dermatological use. It has previously demonstrated favorable efficacy and safety in the phase II clinical trial for mild-to-moderate AD.

　　The successful enrollment of the first patient for VC005 Topical Gel lays a solid foundation for subsequent clinical advancement and will provide key data support for the NDA submmition.

　　In addition to the topical gel formulation, the oral tablet of VC005 is currently in the pre-NDA stage. Leveraging its differentiated dosage form layout, Jiangsu Vcare has achieved full coverage of patients with mild, moderate and severe AD, establishing a comprehensive product portfolio for AD treatment.

　　Jiangsu Vcare will continue to focus on innovative R&D in the field of autoimmune diseases, steadily accelerate the clinical development of its pipeline products, and expedite the research achievements.

　　With a diversified and high-quality innovative product pipeline, the Company is expected to fill the unmet clinical needs in China’s AD treatment landscape and provide safer, more efficient and precise personalized novel treatment options for patients.

　　About VC005 Topical Gel

　　VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor. Both oral and topical formulations with multiple specifications have been developed, forming a product matrix covering multiple therapeutic areas.

　　As a novel JAK1-targeted topical gel for skin exposure, VC005 Topical Gel utilizes a unique pharmaceutical dosage form matrix. While achieving high drug loading, it also features excellent stability, safety, non-irritation, and a refreshing gel texture, greatly improving patient medication compliance.

　　In the completed Phase II clinical trial for mild-to-moderate atopic dermatitis, VC005 Topical Gel demonstrated significant anti-pruritic effects and skin lesion recovery early in treatment: pruritus relief was observed on the first day, with the average Numeric Rating Scale (NRS) for pruritus decreasing by approximately 14% within 12 hours. After one week of administration, at least a 50% improvement in skin lesions (EASI-50 response) was achieved in about 30% of patients, significantly improve their quality of life.

　　In terms of safety, the incidence of treatment-related adverse events (TRAE) was lower than that in the vehicle group, with no serious adverse reactions (SAR) reported, indicating favorable patient tolerability. Regarding metabolism, plasma exposure is extremely low, especially in adolescents, with no drug accumulation. It is expected to address the black box warning issues of marketed topical drugs targeting the same receptor.

　　About Atopic Dermatitis

　　Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease characterized by dry skin, intense pruritus, and eczematous rashes, which severely impacts patients' quality of life. Epidemiologically, the global prevalence of AD is approximately 230 million people. In China, the prevalence of AD among adults ranges from 2% to 8%, with over 70 million patients, including 67% with mild cases and 33% with moderate-to-severe cases. According to F&S forecasts, the number of patients will continue to grow at a compound annual growth rate (CAGR) of 1.7% from 2025 to 2030. Traditional therapeutic drugs, such as glucocorticoids, are associated with numerous adverse reactions and fail to provide long-term benefits, making it difficult to achieve effective and stable disease control. In contrast, topical small-molecule JAK1-targeted inhibitors are non-glucocorticoid immunosuppressants, which are expected to retain therapeutic efficacy with further improvement in the medication safety for patients with mild-to-moderate symptoms.